FDA recall Z-2228-2018

Product

Part #: SAM XT-C, Model: Hi-Viz Blue

Reason for recall

Based on internal testing, results indicated a possible failure of the stitches securing the buckle to the nylon belt could occur, posing a potential risk when used on a human patient to stop arterial blood flow. There is a remote chance that a serious injury and/or death could occur as a result of the failure of the device.

Distribution

USA: CA, MD, OH, FL, ID, CO, CT, OR, AZ, IL, ME, MO, NY, SC, MI, AR, MT, CT, WA, TX, KY, NC, NJ, PA OUS: Australia, Canada, China, Columbia, Costa Rica, Europe (EU), Hong Kong, Iceland, India, Iraq, Israel, Japan, Kenya, Korea, Lebanon, Malaysia, Russia, Saudi Arabia, Singapore, South Africa, Thailand, UAE

Key facts

Status

Terminated

Initiation date

2018-05-02

Report date

2018-06-20

Termination date

2020-07-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Wilsonville, OR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2228-2018